MAUDE Adverse Event Report: SMITH & NEPHEW, INC. A'SCOPE, A'CLAVE, HD, 4MM X 30°; ANTHROSCOPE

Catalog Number 72202087

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2014

Event Type  malfunction  

Manufacturer Narrative

An evaluation was performed on the returned device and the results confirmed the complaint for the scope having a black image.A visual inspection was performed and showed the scope has been used in the field.The distal tip is scratched and there are cannula marks on the base of the needle.The outertube was slightly bent with internal cracked lenses.This is caused by excessive force applied to the outertube.No manufacturing related defects were observed.No further investigation is required.(b)(4).

Event Description

It was reported that during a knee scope procedure using a a'scope, a'clave, hd, 4mm x 30஠it was also reported that there was no image, black and cannot see out of them.A backup device was available to complete the case and there were no reported patient injuries or complications.

• Brand Name: A'SCOPE, A'CLAVE, HD, 4MM X 30°
• Type of Device: ANTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4932935
• MDR Text Key: 22709860
• Report Number: 3003604053-2015-00065
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202087
• Device Lot Number: BBJ952405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1